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Completed

NCT Number: NCT02522351

Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia

The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grand hopital de Charleroi, Charleroi, Belgium

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About this study

This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit).

The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
  • Patients aged between 18 and 85 years
  • Ischemic/hemorrhagic cerebral cause (stroke)
  • Able to understand French (oral and written)
  • Cognitive capacity enough to understand study procedures
  • Having health insurance (which in France is " social security")
  • Having signed the consent form.

Exclusion criteria

  • Any swallowing trouble not resulting from the current stroke
  • History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
  • Any physician diagnosed psychiatric illness
  • Patient with a digestive fistula
  • Any physician diagnosed food allergy
  • Any known allergy to barium or any compound of the contrast product
  • Confirmed or suspected perforated and occlusive syndrome
  • Pregnant or lactating women
  • Major respiratory disease needing oxygen (chronic respiratory insufficiency)
  • Subject who cannot be expected to comply with the study procedures, including consuming the test products.
  • Currently participating or having participated in another clinical trial during the month preceding the study

Treatment and study plan

Cereal extract concentration 1

Other

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 2

Other

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 3

Other

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 1

Other

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 2

Other

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 3

Other

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Primary outcomes

  1. Identification of any systematic effect of cohesiveness on the efficacy of swallowing in dysphagic patients according to Rosenbek's Penetration-Aspiration Score (PAS) using videofluoroscopy

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    The PAS score across each bolus (5 mL and 10 mL)

Secondary outcomes

  1. Swallowing safety- prevalence of penetration

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    The prevalence of penetration in the population according to Rosenbek's PAS (score of 2-5) assessed using videofluoroscopy

  2. Swallowing safety- prevalence of aspiration

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    The prevalence of aspiration in the population according to Rosenbek's PAS (score of 6-8) assessed using videofluoroscopy

  3. Swallowing function- Amount/volume of oral and pharyngeal residues

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    The amount/volume of oral and pharyngeal residues assessed using videofluoroscopy

  4. Swallowing function- Prevalence of subjects with oral and pharyngeal residues

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    The prevalence of subjects of oral and pharyngeal residues assessed using videofluoroscopy

  5. Swallowing function- Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)

  6. Swallowing function- Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)

  7. Swallowing function- Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)

  8. Swallowing function- Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)

  9. Swallowing function-Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)

  10. Swallowing function- Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)

    Time frame: During the ingestion (videofluoroscopy), maximum during one hour.

    Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)

  11. Subjective perception of ease of swallowing and oropharyngeal sensation.

    Time frame: Right after ingredient ingestion, maximum during one hour.

    This will be assessed from a questionnaire.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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